NCT04254315

Brief Summary

The overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in psychological distress with HADS over time in order to optimize time of measuring HADS. (3) To investigate if the intervention can be implemented to other cardiac rehabilitation sites with the same effect as on BFH (that it is not person dependent).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 18, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

January 18, 2020

Last Update Submit

April 21, 2022

Conditions

Ischemic Heart DiseaseHeart Valve DiseasesPsychological Distress

Keywords

Group based cognitive therapyIschemic Heart DiseaseHeart Valve DiseasesPsychological Distress

Outcome Measures

Primary Outcomes (2)

  • The primary outcome of the RCT is anxiety and depression measured by HADS

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.

    3 months follow-up

  • The primary outcome of the RCT is anxiety and depression measured by HADS

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.

    6 months follow-up

Secondary Outcomes (2)

  • Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL

    3 months follow-up

  • Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL

    6 months follow-up

Study Arms (3)

Cardiac rehabilitation+cognitive therapy

EXPERIMENTAL

The intervention group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. In addition, the intervention group follows a standardized group based cognitive therapy program with participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse.

Behavioral: Group based cognitive therapy

Cardiac rehabilitation

NO INTERVENTION

The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. .

Control group without psychological distress

NO INTERVENTION

The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. .

Interventions

Group based cognitive therapyBEHAVIORAL

Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours. The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress. When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising.

Cardiac rehabilitation+cognitive therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HADS score \> 8 for HADS-A or HADS-D
  • Age \< 65 years
  • Able to speak and understand Danish

You may not qualify if:

  • Participation in rehabilitation program within the last 2 years
  • Ejection Fraction (EF) \< 35%
  • Other serious comorbidity that are expected to have a serious impact on life expectancy
  • Known abuse of alcohol or euphoric drugs. Known more serious psychopathology such as schizophrenia, bipolar disorder, severe personality disorder, and treatment with psychoactive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology department, Bispebjerg-Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (7)

  • Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.

    PMID: 21735386BACKGROUND

  • Damen NL, Versteeg H, Boersma E, Serruys PW, van Geuns RJ, Denollet J, van Domburg RT, Pedersen SS. Depression is independently associated with 7-year mortality in patients treated with percutaneous coronary intervention: results from the RESEARCH registry. Int J Cardiol. 2013 Sep 10;167(6):2496-501. doi: 10.1016/j.ijcard.2012.04.028. Epub 2012 May 3.

    PMID: 22560933BACKGROUND

  • van Dijk MR, Utens EM, Dulfer K, Al-Qezweny MN, van Geuns RJ, Daemen J, van Domburg RT. Depression and anxiety symptoms as predictors of mortality in PCI patients at 10 years of follow-up. Eur J Prev Cardiol. 2016 Mar;23(5):552-8. doi: 10.1177/2047487315571889. Epub 2015 Feb 9.

    PMID: 25665581BACKGROUND

  • Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.

    PMID: 21263103BACKGROUND

  • Blumenthal JA, Sherwood A, Smith PJ, Watkins L, Mabe S, Kraus WE, Ingle K, Miller P, Hinderliter A. Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial. Circulation. 2016 Apr 5;133(14):1341-50. doi: 10.1161/CIRCULATIONAHA.115.018926. Epub 2016 Mar 21.

    PMID: 27045127BACKGROUND

  • Zheng X, Zheng Y, Ma J, Zhang M, Zhang Y, Liu X, Chen L, Yang Q, Sun Y, Wu J, Yu B. Effect of exercise-based cardiac rehabilitation on anxiety and depression in patients with myocardial infarction: A systematic review and meta-analysis. Heart Lung. 2019 Jan;48(1):1-7. doi: 10.1016/j.hrtlng.2018.09.011. Epub 2018 Oct 23.

    PMID: 30366575BACKGROUND

  • Holdgaard A, Eckhardt-Hansen C, Lund T, Lassen CF, Sibiliz KL, Hofsten DE, Prescott E, Rasmusen HK. Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress-a randomized controlled trial protocol. Trials. 2021 Jul 16;22(1):455. doi: 10.1186/s13063-021-05405-3.

    PMID: 34271952DERIVED

MeSH Terms

Conditions

Myocardial IschemiaHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized study with * Intervention group * Control group with psychological distress * Control group without psychological distress (not part of randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2020

First Posted

February 5, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

April 1, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)